ID

34326

Descrição

Study of BMS-790052 Add-On to Standard of Care in Treatment Naive Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01125189

Link

https://clinicaltrials.gov/show/NCT01125189

Palavras-chave

  1. 16/01/2019 16/01/2019 -
Titular dos direitos

see on clinicaltrials.gov

Transferido a

16 de janeiro de 2019

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Hepatitis C Virus NCT01125189

Eligibility Hepatitis C Virus NCT01125189

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects chronically infected with hcv genotype 1 or 4
Descrição

ID.1

Tipo de dados

boolean

hcv rna viral load of ≥ 100,000 iu/ml
Descrição

ID.2

Tipo de dados

boolean

no previous exposure to interferon, pegifnα, or rbv
Descrição

ID.3

Tipo de dados

boolean

results of a liver biopsy demonstrating absence of cirrhosis obtained ≤ 24 months prior to randomization. compensated cirrhotics with hcv genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
Descrição

ID.4

Tipo de dados

boolean

ultrasound, ct scan, or mri results 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
Descrição

ID.5

Tipo de dados

boolean

body mass index (bmi) of 18 to 35 kg/m²
Descrição

ID.6

Tipo de dados

boolean

Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive for hepatitis b or hiv-1/hiv-2 antibody at screening
Descrição

ID.7

Tipo de dados

boolean

evidence of a medical condition associated with chronic liver disease other than hcv
Descrição

ID.8

Tipo de dados

boolean

evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Descrição

ID.9

Tipo de dados

boolean

Similar models

Eligibility Hepatitis C Virus NCT01125189

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
subjects chronically infected with hcv genotype 1 or 4
boolean
ID.2
Item
hcv rna viral load of ≥ 100,000 iu/ml
boolean
ID.3
Item
no previous exposure to interferon, pegifnα, or rbv
boolean
ID.4
Item
results of a liver biopsy demonstrating absence of cirrhosis obtained ≤ 24 months prior to randomization. compensated cirrhotics with hcv genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
boolean
ID.5
Item
ultrasound, ct scan, or mri results 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
boolean
ID.6
Item
body mass index (bmi) of 18 to 35 kg/m²
boolean
Item Group
C0680251 (UMLS CUI)
ID.7
Item
positive for hepatitis b or hiv-1/hiv-2 antibody at screening
boolean
ID.8
Item
evidence of a medical condition associated with chronic liver disease other than hcv
boolean
ID.9
Item
evidence of decompensated cirrhosis based on radiologic criteria or biopsy
boolean

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